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Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease Patients

This study has been completed.
Sponsor:
Information provided by:
AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00255424
First received: November 17, 2005
Last updated: October 21, 2008
Last verified: October 2008
History of Changes
  Purpose

The study will evaluate the safety and efficacy of a new intravenously administered iron drug to treat anemia in patients with chronic kidney disease who are not on dialysis.


Condition Intervention Phase
Anemia
 Drug: ferumoxytol or oral iron
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Study of the Safety and Efficacy of Ferumoxytol (Compared With Oral Iron) as an Iron Replacement Therapy in Chronic Kidney Disease Patients Not on Dialysis

Resource links provided by NLM:

Drug Information available for: Ferumoxytol
U.S. FDA Resources

Further study details as provided by AMAG Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • The mean change in hemoglobin from baseline.

Secondary Outcome Measures:
  • Change in iron indices.

Estimated Enrollment: 304
Study Start Date: May 2004
Study Completion Date: August 2006
Detailed Description:

This study will evaluate the efficacy and safety of intravenous (IV) ferumoxytol as compared to oral iron in the treatment of anemia in non-dialysis dependent CKD patients. Patients are randomized to receive either two doses of 510 mg of ferumoxytol within one week or 200 mg oral elemental iron daily for three weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients ≥ 18 years.
  • Have chronic kidney disease per K/DOQI guidelines.
  • No change in EPO status during study.
  • Baseline hemoglobin of ≤ 11.0 g/dl.

Exclusion Criteria:

  • Women who are pregnant or lactating.
  • Received another investigational drug or device within 30 days.
  • Recent parenteral or oral iron therapy.
  • Patients with active GI bleeding or acute bleeding within 4 weeks.
  • Patients that have other causes of anemia.
  • Major surgery within 30 days or anticipated or planned major surgery during the study.
  • Patients whose EPO status changes while on study.
  • Patients with active infections.
  • Recent blood transfusions.
  • Patients with any known allergies to iron products.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00255424

Locations
United States, California
Encino, California, United States, 91356
Riverside, California, United States, 92501
Tarzana, California, United States, 91356
United States, Florida
Ocala, Florida, United States, 34471
United States, Louisiana
Shreveport, Louisiana, United States, 71101
Shreveport, Louisiana, United States, 71103
United States, Massachusetts
Springfield, Massachusetts, United States, 01107
United States, Michigan
Detroit, Michigan, United States, 48236
United States, New York
Flushing, New York, United States, 11355
Orchard Park, New York, United States, 14127
United States, Ohio
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Hershey, Pennsylvania, United States, 17033
Lancaster, Pennsylvania, United States, 17604
United States, Tennessee
Chattanooga, Tennessee, United States, 37404
Knoxville, Tennessee, United States, 37923
United States, Texas
Houston, Texas, United States, 77074
United States, Virginia
Fairfax, Virginia, United States, 22030
United States, West Virginia
Bluefield, West Virginia, United States, 24701
United States, Wisconsin
Appleton, Wisconsin, United States, 54911
Sponsors and Collaborators
AMAG Pharmaceuticals, Inc.
  More Information

Additional Information:
National Kidney Foundation  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00255424     History of Changes
Other Study ID Numbers: 62745-6
Study First Received: November 17, 2005
Last Updated: October 21, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Ferumoxytol
Iron
 Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013